Skills

Title: All type of analytical support. Vendor audit and other QA support.

• To review Analytical Method Verification/Validation Protocols for API/Excipients and finished product as per regulatory requirements and compliance.
• Coordination with internal department of completion of Analytical Method development, validation/ verification, transfer activities with R & D/contract lab for API/Excipients and finished product and prepare specification and standard test procedures for API/Excipients and Finished product based on the Method Verification/Validation Reports.
• To prepared the risk assessment documents for finished products and raw materials like API, Excipients and Packaging Materials as per GMP regulation.
• To prepare Standard Operating Procedure and Company Policies like quality policy, validation policy, cleaning validation policy, calibration policy, training policy etc.
• To prepare Master documents such as specification, STP, Protocols, Annual Product Quality Review reports (APQR). etc. as per regulatory requirements.
• To prepare Qualification documents for Analytical Instruments and Equipment.
• To prepare Product Stability/Hold Time study protocol and report as per the stability policy and SOP with close co-ordination of respective department.
• To perform the Vendor management activity as per standard operating procedure and regulatory requirements and to prepare vendor audit report.
• To prepare investigation and documentation pertaining to quality of product or process e.g. change controls, deviations, Quality incidents, OOSs, OOTs, CAPAs, complaints, recalls pertaining to quality of product or process as applicable.

To review analytical data pertaining to quality of product in accordance with accuracy and correctness for compliance.

• Coordination and complies with contract/service providers.
• Additional responsibility can be assigned as per the company requirements.

Working with all members of staff to develop, improve and maintain the positive quality culture

• To support for regulatory submission activities and Audit activities.
• Analytical document management.

Refrences

• L M Manufacturing Limited (India) (Since 21/08/2017)

Designation: Quality Manager

• To review Analytical Method Verification/Validation Protocols for API/Excipients and finished product as per regulatory requirements and compliance.
• Coordination with internal department of completion of Analytical Method development, validation/ verification, transfer activities with R

Time and Spatial Flexiblity

Saturday , sunday preferable,

Anywhere i can come.

within India is first prefernce.

Travel and accomodation facility on party.

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